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What Is the Software Pre-Cert Pilot Program?

The Software Precertification (Pre-Cert) Pilot Program, as outlined in the FDA's Digital Health Innovation Action Plan [PDF], will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market.

This proposed approach aims to look first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for traditional medical devices. Because software products can be adapted to respond to glitches, adverse events, and other safety concerns quickly, the FDA is working to establish a regulatory framework that is equally responsive when issues arise to help ensure consumers continue to have access to safe and effective products. In the Pre-Cert program, the FDA is proposing that software products from precertified companies would continue to meet the same safety and effectiveness standard that the agency expects for products that have followed the traditional path to market.

This pilot is an important first step to help us explore and evaluate the program model to inform how we establish the Pre-Cert Program. Pre-Cert 1.0, the first version of the program that will be available for pilot testing within the FDA's current authorities in 2019, is limited to Pre-Cert pilot participants’ software as a medical device (SaMD). Learn more about software as a medical device (SaMD). As the FDA leverages insights from testing of Pre-Cert 1.0, we envision offering the voluntary program to manufacturers of software in a medical device (SiMD), and other software that could be considered accessories to hardware medical devices. FDA will consider software that meets the definition of device in section 201(h) (as amended by section 520(o) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in developing the program.

How Does the Pre-Cert Pilot Program Work?

The 2019 Test Plan summarizes how the FDA will test the model in 2019 with certain SaMD De Novo Requests from Pre-Cert pilot participants and internally using selected previously-reviewed SaMD submissions. During this test phase, the FDA will assess whether the Excellence Appraisal and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a software product prior to its introduction to the market, as compared to the traditional paradigm. Learn more about the 2019 Test Plan.

Proposed Key Components of a Future Pre-Cert Program:

Total Product Lifecycle Approach of the Software Precertification Program

The FDA’s Total Product Lifecycle (TPLC) approach enables the evaluation and monitoring of a software product from its premarket development to postmarket performance, along with continued demonstration of the organization’s excellence. Learn more about this approach in the working model.

Excellence Appraisal: Identifying the objective criteria and methodology that the FDA will use to pre-certify a company and decide whether a company can keep its precertification status.

The FDA is currently basing the Pilot Program's criteria on five excellence principles: patient safety, product quality, clinical responsibility, cybersecurity responsibility, and proactive culture. The FDA is currently considering two levels of precertification based on how a company meets the excellence principles and whether it has demonstrated a track record in delivering safe and effective software products.

Review Determination: Developing a risk-based framework so that a precertified company can determine the premarket review pathway for their products. Potentially precertified companies could market their lower-risk devices without FDA premarket review or only a streamlined premarket review based on the company's precertification level and International Medical Device Regulators Forum (IMDRF) risk categorization.

The FDA is planning to leverage the IMDRF framework to help determine the risk categorization of a SaMD product, incorporating information about the medical purpose of the SaMD and the seriousness of the medical condition that the SaMD is intended to treat.

The FDA is also considering appropriate means to educate patients and providers about the premarket review and postmarket monitoring obligations for each SaMD risk category.

Streamlined Review: Identifying the type of information that a precertified company would include in its premarket submission for the FDA to review software products for safety and effectiveness before patients access them.

The FDA is exploring using an interactive streamlined review of a SaMD with information the agency already has gained from the process to precertify a company, and additional information the company would share about the SaMD's product performance, clinical association between the SaMD output and a clinical condition, and safety measures.

Real-world Performance: Identifying the type of information that a precertified company may have access to about how its software product is performing with patients to support the regulatory status of the product and new and evolving product functions.

The FDA is considering how best to work with a company to collect and interpret real-world information about a SaMD and to evolve the product's safety and effectiveness to address any emerging risks. The sources of real world performance data may include information about a user's experience, software performance data, and clinical outcomes.

What is the Goal of the Pre-Cert Pilot Program?

The goal of the program is to have tailored, pragmatic, and least burdensome regulatory oversight that assesses organizations (large and small) to establish trust that they have a culture of quality and organizational excellence such that they can develop high quality SaMD products, leverages transparency of organizational excellence and product performance across the entire lifecycle of SaMD, utilizes a tailored streamlined premarket review, and leverages unique postmarket opportunities available in software to verify the continued safety, effectiveness, and performance of SaMD in the real-world.

The Software Precertification (Pre-Cert) Program's aims are to:

Benefit a participating organization based on its "precertified" status by offering the ability to participate in a streamlined premarket review and opportunities to collect and leverage real-world postmarket data.

Leverage and use information and data from all available sources allowing FDA and SaMD manufacturers to be more efficient and streamlined without compromising safety and effectiveness of SaMD products.

Enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion.

Ensure high-quality software products throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organizational excellence.

Adapt key elements and measure based on the effectiveness of the program.

Who Is Currently Involved in the Pre-Cert Pilot Program?

In September 2017, the FDA selected nine companies out of over 100 applicants to participate in the development of the Software Pre-Cert pilot program:

The FDA also hired three Entrepreneur-in-Residence fellows to help support the development of the Pre-Cert Program.

How You Can Get Involved with the Pre-Cert Pilot Program

The FDA continues to seek input on the Pre-Cert working model from the public through the public docket by March 8, 2019. The FDA encourages stakeholders to self-organize as groups and provide consolidated feedback on the Pre-Cert working model. Your input will help shape the next steps that we take to build the Pre-Cert program.